Clinical Trial Evaluating the Safety and Efficacy of the Use of Chitosan Gel in Patients With Chronic Wounds

A Randomized, Parallel, Double Blind, Placebo Controlled, Multicentre, Two Arms Clinical Trial Evaluating the Safety and Efficacy of the Use of Chitosan Gel in Patients With Chronic Wounds

Type 1 and Type 2 diabetic patients with diabetic foot ulcer will be recruited and screened for participation in the study. Eligible patients will be randomized 1:1 to either experimental or control group and undergo 10-weeks of treatment (as an addition to standard care) and 4 weeks of follow-up to evaluate the effect of chitosan gel on chronic wound (diabetic foot ulcer) healing.

Inclusion Criteria:

• Written informed consent must be given

• Patient ≥ 18 years old

• Diagnosed with type I or type II diabetes mellitus

• Glycosylated haemoglobin, HbA1c, ≤ 12%

• Presence of diabetic foot ulcer or an amputation wound that meets following criteria:

  1. Size of the wound 0,5 - 12 cm^2
  2. Wagner grade I or II
  3. Wound is not infected
  4. Wound present for at least 4 weeks

• If multiple wounds are present, the biggest wound fitting the criteria is selected and the distance from other wounds must be at least 2 cm

• If there is an amputation wound present, it can be used for the purpose of this study if it fits the rest of the criteria

• Adequate perfusion (good, strong foot pulses). If foot pulses are weak, evaluation of perfusion pressures with Doppler ultrasound is performed.

• Able to understand and comply with the requirements of the trial

Exclusion Criteria:

• Known history of alcohol or drug abuse
• Use of any antibiotic medication within the last 7 days prior to the first application of study product
• Patients presenting with Wagner Grade III or higher ulcer
• Patients with serious concomitant disease (cancer, heart failure ( NYHA class IV), severe anemia (Hb<100 g/L), neoplasia)
• Any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness)
• Patients that will require surgical procedure to treat their ischemic condition on the limb where the wound is present as assessed by the doctor
• Excessive lymphedema that could interfere with wound healing (if there is mild edema treated with compression therapy the patient can be included)
• Patients diagnosed with autoimmune connective tissues diseases
• Previous treatment under this clinical protocol
• Participation in another clinical trial up to 30 days before the randomization visit.
• Receiving or scheduled to receive a medication or treatment which, in the opinion of the investigator, was known to interfere with, or affect the rate and quality of wound healing
• Medical condition likely to require systemic corticosteroids during the study period
• Allergic to shellfish, chitosan or one of ChitoCare product compounds
• Immobile patients
• Pregnant and lactating women
• Significant increase in wound healing during run-in period (reduction of wound size area ≥ 40%)
• BMI > 39 kg/m2